NCT04494152

Brief Summary

The purpose of this study is to assess reliability of echocardiographic assessment of ventricular dimensions and function from subcostal view.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

August 24, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

July 28, 2020

Last Update Submit

August 20, 2020

Conditions

Transthoracic Echocardiography

Outcome Measures

Primary Outcomes (2)

  • Reliability of left ventricular subcostal fractional shortening and left ventricular modified subcostal fractional shortening in determining the global left ventricular systolic function in critically ill patients.

    Left ventricular subcostal fractional shortening and left ventricular modified subcostal fractional shortening are new potential echocardiographic parameters of left ventricular systolic function measurable from subcostal view.

    During the procedure

  • Reliability of right ventricular subcostal fractional shortening and right ventricular modified subcostal fractional shortening in determining the global right ventricular systolic function in critically ill patients.

    Right ventricular subcostal fractional shortening and right ventricular modified subcostal fractional shortening are new potential echocardiographic parameters of right ventricular systolic function measurable from subcostal view.

    During the procedure

Secondary Outcomes (2)

  • Reliability of echocardiographic parameters evaluating the structure of the left ventricle measured in a subcostal view in critically ill patients.

    During the procedure

  • Reliability of echocardiographic parameters evaluating the size of the right ventricle measured in a subcostal view in critically ill patients.

    During the procedure

Study Arms (1)

Critically ill patients

Adult critically ill patients hospitalised in the intensive care unit.

Diagnostic Test: Transthoracic echocardiography

Interventions

Transthoracic echocardiographyDIAGNOSTIC_TEST

Standard Point-of-Care echocardiographic examination in the intensive care unit.

Critically ill patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult critically ill patients.

You may qualify if:

  • Inpatients
  • All patients hospitalised in intensive care unit indicated for transthoracic echocardiography examination

You may not qualify if:

  • Age \<18 years
  • Insufficient imaging quality of transthoracic echocardiography
  • Refusal of echocardiographic examination by patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masaryk Hospital Usti nad Labem

Ústí nad Labem, 40113, Czechia

RECRUITING

Related Publications (1)

  • Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.

    PMID: 25559473BACKGROUND

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Roman Skulec, MD, PhD

    Masaryk Hospital Usti nad Labem

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roman Skulec, MD, PhD

CONTACT

00420777577497skulec@email.cz

Barbora Pakostova, MD

CONTACT

00420720172670Barbora.Pakostova@kzcr.eu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 31, 2020

Study Start

August 20, 2020

Primary Completion

July 28, 2021

Study Completion

October 31, 2021

Last Updated

August 24, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)